One of the problems with the recommendations of the AHA (American Heart Association) is that we just seem to assume that Class IIb means that a treatment is good. Look at the description of the different classes of recommendation.
The classes of recommendation used in this document are listed in Table 3. These classes represent the integration of the weight of scientific evidence with contextual factors such as expert assessment of the magnitude of benefit, usefulness, or efficacy; cost; educational and training challenges; and difficulties in implementation.[1]
Here is the table –
Table 3.
Applying Classification of Recommendations and Level of Evidence–
Class I
Benefit >>> Risk
Procedure/treatment or diagnostic test/assessment should be performed/administered.–
Class IIa
Benefit >> Risk
It is reasonable to perform procedure/administer treatment or perform diagnostic test/ assessment.–
Class IIb
Benefit ≥ Risk
Procedure/treatment or diagnostic test/assessment may be considered.–
Class III
Risk ≥ Benefit
Procedure/treatment or diagnostic test/assessment should not be performed/administered. It is not helpful and may be harmful.–
Class Indeterminate.
• Research just getting started
• Continuing area of research
• No recommendations until further research (eg, cannot recommend for or against)[2]
Ideally all CPR and ECC recommendations should be based on large prospective randomized controlled clinical trials that find substantial treatment effects on long-term survival and carry a Class I or Class IIa label.[1]
Ideally.
In reality few clinical resuscitation trials have sufficient power to demonstrate an effect on intact survival to hospital discharge.[1]
But . . .
As a result the experts were often confronted with the need to make recommendations on the basis of results from human trials that reported only intermediate outcomes, nonrandomized or retrospective observational studies, animal models, or extrapolations.[1]
We feel that it is much more important to do something and just assume that because we are doing it, it is good.
I might have more confidence in these recommendations, if these experts had demanded that this research be completed before the next revision of the guidelines or all of the Class IIb recommendations would automatically become Class Indeterminate.
Without valid research, this is just unprofessional, unethical, uncontrolled, unauthorized, unreasonable experimentation on people who are just too dead to run away. And without any attempt at informed consent.
The excuse used by IRBs (Institutional Review Boards) and other amateur ethicists –
You can’t study this because the treatment is the Standard Of Care.
To deprive a patient of the Standard Of Care would be unethical.
This Standard Of Care is an optimistic guess.
By preventing the valid experiments, the IRBs are just requiring uncontrolled experimentation. They just call that kind of abuse of patients the Standard Of Care.
These ethicists base the Standard Of Care on the AHA guidelines. If the AHA had written it into the guidelines that all Class IIb treatments must be studied in at least one huge randomized double-blinded placebo controlled study, it would be difficult for the IRBs and others to claim that their perverse interpretation of one part of the guidelines overrules another part of the guidelines written specifically to point out hat these IRBs need to demand investigation of the so called Standard Of Care.
This Standard Of Care is based less on extremely weak evidence than it is on wishful thinking.
Perhaps Class IIb and the Standard Of Care should be represented this way –
Wishful Thinking >>> Evidence
Class IIb recommendations fall into 2 categories: (1) optional and (2) recommended by the experts despite the absence of high-level supporting evidence. Optional interventions are identified by terms such as “can be considered” or “may be useful.” Interventions that the experts believe should be carried out are identified with terms such as “we recommend.”[1]
In other words, we have Class IIb broken down further. This is getting to be like the tax code.
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Class IIb – Optional – This is a long shot. We just did not feel like making it Class Indeterminate.
Class IIb – Recommended – This is the same as Class IIb – Optional, only more so.
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Expert recommendations must come with an expiration date.
No exceptions.
We must not Grandfather in wishful thinking.
Our patients deserve better.
Our patients deserve real ethical treatment.
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Continued in Ethics, Research, and IRBs – Part II and later in Ethics, Research, and IRBs – Part III.
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Footnotes:
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[1] Guidelines and Treatment Recommendations
2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Part 1: Introduction
Free Full Text
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[2] Table 3. Applying Classification of Recommendations and Level of Evidence
2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Part 1: Introduction
Table 3
I have modified this table solely for the purpose of clarity of presentation, by modifying color and font. None of the words have been changed.
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You have hit on a topic that is near and dear to me. The IRB and the ability for people to do “studies” with or without IRB approval. One thing that must be looked at is whose IRB is overseeing a “study”.
An IRB is directly connected to a healthcare institution with the exception of governmental Department of Health offices. An IRB must work within the institution that it is developed from. This is where a huge problem exists for studies performed that relate to EMS. A physician who wants to do a study in EMS has to go to his or her institution’s IRB. An institution that more than likely has no connection to the EMS study other than the physician who wants to do the study works at that institution.
More appropriate studies need to be done not only in the world of EMS, but in all areas of healthcare. It seems that we have been seeing more and more studies coming out, but the scope of those studies seem to be very narrow, short in duration and have too few patient numbers to make a wide spread change in the everyday treatment of patients. In my opinion, we have too many physicians and other healthcare providers who want to get their names in an article so they do a quick study. We can make statistics look how ever we want to, but unless you have a solid study with large numbers of patients, the study really doesn’t mean much. You may be able to get your name on the study, printed in an article and then do some lectures, but is that really helping our patients? Now we are seeing these studies effecting AHA Guidelines that we all want to blindly follow.
Until there is stricter oversight by appropriate IRB’s, the outcomes of these studies will continue to come in to question. I would suggest that each state have an IRB through their Department of Health that oversees all EMS studies within their state. This way you are taking out any favoritism by a physician doing a study through their own institution, which has no connection to EMS at all. This doesn’t solve the issues of the non-EMS studies, but it is a step in the right direction to give EMS studies more validity and remove some of the doubt of why someone is doing a study.
Studies that change how we treat our patients need to take time to complete. We need to stop being in a hurry to change everything and allow appropriate studies to be completed.